This invention relates to the field of fixating fitments or holder apparatus for medical tubes, such as medical breathing tubes. It is often a medical necessity to establish an artificial airway in a person with breathing difficulties. Such artificial airway is commonly accomplished by the insertion, via the mouth or nose, of a breathing tube into the trachea. Such breathing tube is often referred to as an endotracheal or tracheal tube. After insertion, it then becomes necessary to secure, fixate and stabilize the tube so that the tube does not migrate out of nor too deeply into the trachea, or cause other complications.
The most common method of fixating a breathing tube is to use adhesive tape. The disadvantages to using adhesive tape are manifold, not the least of which is difficulty in learning effective techniques for applying the tape properly. Length of time in applying, the need for preparing the patient""s skin with chemicals so the tape will adhere, and the need for removing facial and other body hair are techniques which must be learned and which take time to carry out in actual practice, where time can be a vital consideration. There is also associated breakdown of the taping system and the erosion and/or necrosis of skin, lips and other tissues.
If the tracheal tube must be repositioned or changed, which frequently must be done, all old tape and its residues must be removed and steps for re-taping taken. The adhesive tape must be frequently changed for positioning or for hygienic or appearance reasons. The use of adhesive tape can also be very time consuming for the doctors, patient care technicians and nurses, as in most cases it takes several minutes to fixate the tube and it often requires two persons to apply: one to hold the tube in position, while the other fixates the tube.
Some other disadvantages of adhesive tape are that it is affected by body secretions and other liquids, body temperatures, changes in patient""s anatomy from swelling or surgical procedures, and the position of the patient.
Any one or a combination of the aforementioned disadvantages can cause great discomfort to the patient and can directly or indirectly result in inadvertent or undesirable displacement of the tracheal tube. This displacement can cause loss or reduced effectiveness of the artificial airway, thus frequently leading to emergency medical situations and even to loss of life.
In current medical practice, more patients are being tracheally and/or endotracheally intubated and for longer periods of time than formerly. These longer time periods have greatly increased the importance of maintaining tube position, performing oral care, and maintaining and preserving the integrity of all tissues and surfaces that are involved.
There have been many attempts to overcome the problems associated with fixating and maintaining tracheal tubes through the use of fixating, holding and securing devices.
Some of these previous attempts include, but are not limited to: U.S. Pat. No. 3,602,227 (Andrew); U.S. Pat. No. 3,760,811 (Andrew); U.S. Pat. No. 3,993,081 (Cussell); U.S. Pat. No. 4,249,529 (Nestor); U.S. Pat. No. 4,284,076 (Hall); U.S. Pat. No. 4,351,331 (Gereg); U.S. Pat. No. 4,392,858 (George); U.S. Pat. No. 4,449,527 (Hinton); U.S. Pat. No. 4,483,337 (Clair); U.S. Pat. No. 4,683,882 (Laird); U.S. Pat. No. 4,744,358 (McGinnis); U.S. Pat. No. 5,076,269 (Austin); U.S. Pat. No. 5,069,206 (Crosbie); and U.S. Pat. No. 5,026,352 (Anderson). Two other patents were considered relevant by the Examiners in the above-reference U.S. Ser. No. 08/015,555, of which this is a continuation-in-part: U.S. Pat. Nos. 2,908,269 (Cheng); and 4,872,579 (Palmer). Certain other patents were cited by said Examiners as being xe2x80x9cof interestxe2x80x9d.
Many of the devices proposed in these patents are uncomfortable to the patient, do not reliably maintain the tube in proper position at all times, restrict patient movement, and are difficult to apply and reapply or reposition. Many of the devices also include inherent design flaws that can easily compromise the basic safety of the patient, and make maintenance of all associated tissues and surfaces difficult.
Some devices, such as the Crosbie, Gereg and McGinnis patents, disclose a device which includes a xe2x80x9cbite blockxe2x80x9d. However, only a very small percentage of patients require a bite block For the greatest number of patients, it is yet another intrusion into the oral area which creates more difficulties and discomfort.
The Crosbie patent also discloses a device that may quite readily cause pinching of the tracheal tube, thus narrowing the internal lumen of the tube and occluding or restricting the flow of gas to the point that it easily may be detrimental to a patient""s ability to exchange gas, thus itself seriously compromising respiration. Crosbie relies on a component living hinge to allow the opening and closure of two rigid half disks with discrete cutaway spaces for engaging tubes of a size to engage snugly within the predetermined spaces on closure of the half disks. This device is extremely cumbersome and has little practical utility.
The Austin patent discloses a two-piece tracheal tube retaining device which requires a ring clamp type mechanism and a special separate collar in order to be operative. It is awkward to apply, can be uncomfortable to the patient because of the torque exerted by the harness at the xe2x80x9cearsxe2x80x9d of the collar where the harness is attached, and can irritate the patient""s mouth because it is designed to engage the patient""s lips. It also obstructs medical observation of the lip.
The Hinton patent discloses a tracheal tube holder which has an interior which is of a spongy material which should be avoided for hygiene reasons. The clamp device of the patent would significantly obstruct the patient""s mouth at the lower part of the tube.
The McGinnis tube holder patent discloses a bulky system that is obstructive to the mouth and requires a large and complex head gear system to hold the tube in place.
The Anderson patent discloses a tube fitment device which has a flange plate which is obstructive to oral areas.
The Cheng patent appears to lack any discernible relevance. It has a passageway through which a tube can be guided to an interior portion of a metal plate and then locked in place with a shoe and cam. But it is not suitable for, nor suggestive of, a device which provides for the securing of an auxiliary tube at or near the upper edge of the plate.
Palmer does not relate at all to endotracheal tube holders but rather to a ventilating and aspirating assembly. It has markers which merely indicate xe2x80x9copenxe2x80x9d and xe2x80x9cclosedxe2x80x9d alignment of two concentric cylinders, and does not in any way disclose or suggest markers in the present invention which indicate degrees of tightness of a ring of shrinking circumference.
It is the general object of the present invention to provide a medical tube holder apparatus which fixates a medical tube and alleviates the problems mentioned above.
A tube fixating device in accordance with the present invention is quickly and easily applied, and is economical to manufacture and use.
The device is reliable for holding the tube in position while maximizing patient comfort and for maintaining the integrity of the associated tissues.
According to one embodiment of the present invention, there is provided a medical tube fixator/fitment device or medical tube holder apparatus of a flexible, resilient material with no component hinge in a generally circular flexible elongated strip shape with releasable locking members (but, for patient security, not transversely releasable) and ported securing ears located on each end so that the ends of the circle may be joined, causing the interior wall of the device to grip or grasp the tube. Included on the interior wall of the circular device are ridges or other good frictional surface to grip better the exterior wall of a tube. Another aspect of the present invention is a travel limiting locking device which prevents occlusion of a medical tube. A circular shaped device is considered the preferred embodiment because the tubes to be engaged are generally circular or cylindrical, and a circular fixating device can engage and touch more points on the circumference of the tube i.e., substantially the entire circumference of the tube at the location of the engagement, than can other configurations and thus provide more friction.
Another aspect of the present invention is a positioner notch which is located on one of the ends of the circular device for the placement and retention of a cuff inflation line or other auxiliary medical tube which is often used in conjunction with an endotracheal tube.
Yet another aspect includes alignment dots, dimples or other markings to indicate that the tube fixating device or holder apparatus is in an appropriately closed or locked position appropriate to the size of the tube for which it is designed to be used. This prevents undue looseness, on the one hand, and undue tightness which might pinch and narrow the interior passage area of the tube.
The fixating devices or holder apparatus may also be color coded or otherwise coded for size so that the possibility of error in matching the devices to the appropriately sized tubes is minimized.
An object of the present invention is to provide a device or apparatus which is not affected by facial hair, body secretions or other liquids, facial anatomy, or body temperatures and maintains the medical tube in a reliably stable and secure position. The need to shave the skin or prepare it with chemicals is eliminated.
A further object of the present invention is to provide a device or apparatus which may be randomly positioned so as to allow for an endotracheal tube to be positioned toward or away from a specific part of the anatomyxe2x80x94for example, keeping the tube positioned to one side of the face when surgery is being or has been performed on the other, or retaining the tube in nasal insertion mode as opposed to oral insertion mode.
In accordance with the invention, the tube fixating device or medical tube holder apparatus is of relatively small size and low profile, weighing less than one ounce and having a cross-sectional thickness of the strip portion of the invention less than one centimeter, so that obstruction of the oral or facial area is minimized and medical observation of the patient""s mouth area is facilitated. The device is also inexpensive.
The retention system of the present invention provides a versatile means of securing the device to the patient""s head and neck. A suggested harness assembly is provided in the following illustrations, but other means such as string or small diameter flexible tubing may be employed.
Other objects and advantages appear in the following description and may be readily appreciated when considered in connection with the accompanying drawings.